Have you or your loved ones been diagnosed with mild cognitive impairment?

You may be eligible to participate in a mild cognitive impairment clinical trial.

Have you or your loved ones been diagnosed with mild cognitive impairment? You may be eligible to participate in a mild cognitive impairment clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Mild Cognitive Impairment Clinical Trial in Edmonton Alberta

NCT02240459 | Phase 2 | Interventional

Have you or your loved ones been diagnosed with mild cognitive impairment?

You may be eligible to participate in a mild cognitive impairment clinical trial.

Have you or your loved ones been diagnosed with mild cognitive impairment? You may be eligible to participate in a mild cognitive impairment clinical trial.

Completed

Male & Female

75 Years +

This study has recruited 47 Participants

The purpose of this study is to assess the effects of fesoterodine at 4mg and 8mg doses versus a placebo and oxybutynin 5mg bid versus placebo on cognitive abilities in older people with overactive bladder and mild cognitive impairment.

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Details for the study

Brief Title

A Study of Fesoterodine and Oxybutynin on Cognitive Function in Mild Cognitive Impairment

Official Title

A Double Blind, Randomized Four Way Cross Over Study to Compare the Effect of Fesoterodine 4mg and 8mg Once Daily and Oxybutynin 5mg Twice Daily After Steady State Dosing Versus Placebo on Cognitive Function in Subjects With Overactive Bladder, Over the Age of 75 Years With Mild Cognitive Impairment

Brief Summary

The purpose of this study is to assess the effects of fesoterodine at 4mg and 8mg doses<br /> versus a placebo and oxybutynin 5mg bid versus placebo on cognitive abilities in older people<br /> with overactive bladder and mild cognitive impairment.

Detailed Description

This is a randomized placebo controlled, blinded four way cross over trial of the effect of
medications used to treat overactive bladder on the cognition of older men and women with
mild cognitive impairment. Each treatment phase is a week, with a weeks washout period before
starting the next treatment. Cognitive testing is by way of a validated computer assisted
battery of tests

Treatments and/or Procedures

Fesoterodine 8mg

2, 4mg fesoterodine capsules taken together in the morning

Fesoterodine 4mg

7 days therapy followed by seven days washout. Each 4mg tablet is taken in the morning

Oxybutynin

5mg IR oxybutynin taken bid, encapsulated into a form indistinguishable from placebo

Placebo

placebo capsule, one twice daily, and 2 placebo fesoterodine tablets taken each morning for masking and comparator purposes

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

continuity of attention

Continuity of Attention: Accuracy of responding in Choice Reaction Time task Percent Target Detection in Digit Vigilance task False Alarms in Digit Vigilance task

1 and 4h post dose

Secondary

cognitive function

includes the following domains of cognition power of attention, quality of working memory, quality of episodic secondary memory, speed of memory Montreal Cognitive assessment score

1 and 4h post last dose of study drug

Study Criteria

Inclusion Criteria:

1. The subject is either male or female and ≥ 75 years of age.

2. The subject has OAB as determined by ICS criteria

3. The subject has mild cognitive impairment as determined by NIA criteria

4. The subject is competent to give informed consent and perform the tasks associated
with the study

5. The subject has a body mass index (BMI) between 18.0 to 30.0 kg/m2 inclusive.

6. Written informed consent has been obtained.

7. The subject is available to complete the study.

8. At training visits (visit 2): the subject has performed at or above the minimum level
on at least one occasion for each individual task measure in cognitive function test
training.

Exclusion Criteria:

1. The subject does not have OAB.

2. The subject has either dementia or moderate to severe cognitive impairment at
screening.

3. The subject has probable clinical depression as determined by Geriatric Depression
Scale (GDS) short form >5 at screening.

4. Subjects taking any cognitive enhancers (cholinesterase inhibitors or memantine).

5. The subject has a history of allergy to the study drug(s), to any component of the
dosage form or any other allergy, which, in the opinion of the Investigator,
contraindicates their participation.

6. The subject has any clinically significant abnormal heart rate or blood pressure
measurements, at the screening visit, which, in the opinion of the Investigator,
prevent safe participation in the study. (dBP< 60mmHg or > 90mmHg, sBP < 95mmHg or >
160mmHg or HR < 40bpm or > 100bpm).

7. Subjects with known history of urinary retention, severe gastrointestinal obstruction
(including paralytic ileus or intestinal atony) or severe gastrointestinal conditions
(including toxic megacolon or ulcerative colitis), myasthenia gravis, uncontrolled
narrow angle glaucoma or shallow interior chamber or subjects deemed to be at risk for
these conditions.

8. Subjects undergoing haemodialysis or who have severe renal impairment.

9. Subjects with severe hepatic impairment, defined as Child-Pugh grade IV.

10. Subjects taking potent CYP 3A4 inhibitors which would, under normal circumstances,
require adjustment of the dose of the test drugs.

11. Subject has taken prescribed medication within 14 days prior to the first study day or
over-the-counter medicine (including vitamins and herbal remedies) within 48 hours
prior to the first study day, which in the opinion of the Investigator, will interfere
with the study procedures or compromise safety.

12. Subject has an average weekly alcohol intake of greater than 21 units (male) or 14
units (female) within the 90 days prior to the study. 1 unit is 270cc of beer, 40cc of
spirits or 125cc of wine.

13. History of smoking more than 10 cigarettes (or the equivalent amount of tobacco) per
day within the 90 days prior to the study.

14. Subject has participated in any clinical study within the last 90 days.

15. Any clinically significant abnormality following Investigator review of the pre study
physical examination.

16. Any clinical condition, which, in the opinion of the Investigator, would not allow
safe completion of the study.

17. Any subjects who, in the opinion of the investigator, may find it difficult to adhere
to the provisions of treatment and observation specified in the protocol.